Phase 2 Lymphoma Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You are 18 years of age or older
• You have been diagnosed with CLL (chronic lymphocytic leukemia) or small lymphocytic lymphoma (SLL) according to established medical guidelines
• You have never received chemotherapy, immunotherapy, or targeted therapy for CLL/SLL (limited exceptions include radiation for comfort, rituximab for autoimmune conditions, or steroids for symptom control)
• Your CLL/SLL is active enough to need treatment, shown by at least one of the following: worsening anemia or low platelet counts; a very enlarged spleen causing symptoms; very large or growing lymph nodes; rapidly increasing white blood cell counts; anemia or low platelets caused by the immune system that are not responding to standard treatment; the disease affecting organs outside the lymph nodes (such as skin, kidneys, lungs, or spine); or symptoms such as losing 10% or more of your body weight without trying, severe tiredness, unexplained fevers over 100.5°F lasting 2+ weeks, or night sweats lasting a month or more
• You are generally able to carry out basic daily activities (your doctor will assess this using a standard scale)
• Your blood counts, liver function, and kidney function meet minimum levels set by the trial (your doctor will check these)
• If you are a woman who could become pregnant and are sexually active, you must be willing to use highly effective birth control during treatment and for a specific period after the last dose of each study drug
• You are willing and able to attend all required study visits and follow the study procedures
• You are able to understand what the study involves and are willing to sign a consent form

Who may not be able to join:

• You have certain high-risk genetic features of CLL, specifically a deletion in chromosome 17p, a TP53 gene mutation, or three or more chromosomal abnormalities (confirm with trial site)
• You are currently taking, or need to take, certain medications that strongly interact with the study drugs (known as moderate or strong CYP3A inhibitors or inducers) (confirm with trial site)
• Your CLL/SLL has spread to your brain or spinal cord
• You have another cancer that is expected to significantly shorten your life or would make it hard to evaluate side effects from this trial
• You have significant heart problems, such as a recent heart attack (within the last 6 months), heart failure, or certain serious heart rhythm problems (note: people with controlled atrial fibrillation may still be eligible)
• You are unable to swallow pills or have a serious digestive condition that would prevent the study drugs from being absorbed properly
• You have a known history of HIV infection
• You currently have an active infection requiring intravenous (IV) antibiotics or antiviral treatment (you may be reconsidered once the infection is resolved)
• You have had a known allergic or severe reaction to any of the study drugs or their ingredients
• You have active bleeding or a known bleeding disorder such as hemophilia or von Willebrand disease
• You have uncontrolled autoimmune destruction of red blood cells or platelets that is not related to your CLL
• You have an uncontrolled autoimmune disease requiring more than 20mg of prednisone (or equivalent steroid) per day
• You have had a stomach or intestinal ulcer confirmed by a procedure within the last 3 months
• You are currently taking warfarin or a similar blood-thinning medication
• Your blood clotting test results are significantly abnormal (confirm with trial site)
• You have had a stroke or bleeding in the brain within the last 6 months
• You have had major surgery within the last 28 days before starting the study
• You have active hepatitis B or C infection (certain people with past hepatitis B or C exposure may still be eligible depending on further test results — confirm with trial site)
• You are pregnant or breastfeeding
• You have received a live vaccine within 28 days before joining the study
• You are currently participating in another treatment clinical trial

Important: Always verify eligibility with the trial site directly before applying.